| Class 2 Device Recall Active I PTH ELISA | |
Date Initiated by Firm | April 22, 2010 |
Date Posted | December 09, 2010 |
Recall Status1 |
Terminated 3 on May 07, 2012 |
Recall Number | Z-0584-2011 |
Recall Event ID |
56250 |
510(K)Number | K952199 |
Product Classification |
Radioimmunoassay, parathyroid hormone - Product Code CEW
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Product | Active I-PTH ELISA, Part Number: DSL-10-8000
The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism. |
Code Information |
Lot Numbers: 992751 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 200 S Kraemer Blvd Brea CA 92821-6208
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For Additional Information Contact | Clair K. ODonovan, Ph.D. 714-961-4483 |
Manufacturer Reason for Recall | The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected by the recall.
The affected I-PTH ELISA and the I-PTH IRMA kit lots may produce falsely elevated patient results. Internal stability testing showed an average 16% elevation for I-PTH ELISA lot 99 |
FDA Determined Cause 2 | Pending |
Action | Beckman Coulter sent an Urgent Product Corrective Action Letter to their consignees dated June 18, 2010. The letter identified the product, the problem, and the action to be taken. Consignees were instructed to:
(1) Discontinue use of all materials provided with I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372.
(2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if their laboratory uses only the Control materials provided with the I-PTH ELISA and IRMA kits.
(3) Abnormal elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests.
(4) I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372 will no longer be shipped. Due to the calibrator instability recently encountered with DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays, Beckman Coulter has decided to immediately discontinue these two part numbers.
Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that they received this important notification.
If they have any unused product the were asked to contact the numbers listed below:
(1) In the United States, contact Customer Service at 1-800-526-382.1
(2) Outside of the United States, consignees were asked to contact their local Beckman Coulter Representative
Consignees were told to contact DSL Technical Support Center at 1-800-231-7970 in the United States, or their local Beckman Coulter Representative with any questions.
For questions regarding this recall call (714) 961-3634. |
Quantity in Commerce | 3 kits |
Distribution | Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CEW
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